Sun Pharmaceutical Industries Ltd is a leading global pharmaceutical company headquartered in India, specializing in generic and specialty medicines. With a strong presence in over 100 countries, Sun Pharma is committed to innovation, quality, and regulatory excellence.
Job Title: Executive – Regulatory Affairs
Location: Tandalja – R&D
Date Posted: July 4, 2025
Job Description
As an Executive – Regulatory Affairs, you will play a crucial role in ensuring compliance with USFDA regulations for drug labeling and submissions. Your responsibilities will include:
- Preparation & review of labeling for ANDA/NDA applications and responses to FDA queries.
- Structured Product Labeling (SPL)Â development for drug listing as per USFDA guidelines.
- Timely submission and coordination of labeling updates based on FDA notifications and RLD changes.
- Collaboration with cross-functional teams to ensure smooth product launches.
- Regulatory filings, labeling artwork management, and compliance tracking.
- Communication with third-party distributors for labeling requirements.
- Evaluation and coordination of REMS (Risk Evaluation & Mitigation Strategies) for submissions.
Eligibility & Skills Required
- Education: Bachelor’s/Master’s in Pharmacy, Life Sciences, or related field.
- Experience: 2-4 years in Regulatory Affairs (USFDA) with expertise in labeling & compliance.
- Technical Skills: Proficiency in SPL, eCTD submissions, and regulatory software.
- Soft Skills:Â Strong communication, attention to detail, and teamwork.
Benefits & Perks
- Competitive salary & performance bonuses.
- Health insurance & wellness programs.
- Career growth in a global pharmaceutical leader.
- Work in a collaborative R&D environment.
